Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 3:05 PM
Ignite Modification Date: 2025-12-25 @ 1:27 PM
NCT ID: NCT04428359
Description: None
Frequency Threshold: 5
Time Frame: 6 months
Study: NCT04428359
Study Brief: A Comparative Study to Assess Efficacy of Intralesional MMR Vaccine and Intralesional Vitamin D3 in Treatment of Warts
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Vitamin D3 All Group B patients will receive intralesional Vitamin D3 Vit D: Group B patients will receive a maximum of 0.5 mL Inj. Vitamin D3 (600,000 IU; 15mg/ml) in each session after injection of IL lignocaine with 31 G insulin syringe. In cases of multiple warts, a maximum of 5 warts will be injected at a time. The session will be done at 3 weekly intervals for a maximum of 5 sessions or until complete resolution of warts, whichever is earlier 0 None 6 30 30 30 View
Measles, Mumps, Rubella Vaccine All Group A patients will receive intralesional MMR. Measles-Mumps-Rubella Vaccine: Group A patients will receive intralesional injection of upto 0.5 mL of reconstituted MMR vaccine into a single or a maximum of 5 warts at a time in case of multiple warts. Intralesional injection will be given every three weeks for a maximum of 5 doses or until complete resolution, whichever is earlier. 0 None 0 31 31 31 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypervitaminosis D NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypopigmentation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Swelling NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hyperpigmentation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View